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E-MASIMO Saturation Module

by GE Healthcare Finland Oy

510(k) K081870

Active European Union and United States

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K081870↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Special NumberK081870 Date31 Jul 2008ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

Full name
Masimo Compatible Saturation Module, E-Masimo
510(k) Number
FDA product code
DQA
Device class
Class II
Regulation
21 CFR Part 870.2700
Advisory committee
Cardiovascular
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The E-MASIMO Saturation Module is a Masimo-compatible pulse oximetry module designed for noninvasive monitoring of arterial oxygen saturation (SpO₂) and pulse rate. It employs Masimo SET® technology, utilizing infrared and red light transillumination to measure oxygenation levels even in challenging clinical scenarios, such as motion artifact or low perfusion conditions.

This single-width, plug-in module integrates with GE Datex-Ohmeda S/5 modular monitoring systems and compatible GE CARESCAPE platforms. Supplied as a reusable device, it adheres to IEC 60601-1 (3rd edition) safety standards. Authorized under FDA 510(k) clearance (K081870) and MDR compliance, it is intended for use in clinical settings where continuous SpO₂ and pulse rate monitoring are required.

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Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • Is this saturation module designed for single-use or can it be reused in clinical settings?

    This module is explicitly labeled as a reusable device, meaning it is intended for repeated use in clinical environments after proper cleaning and maintenance. Since it adheres to IEC 60601-1 (3rd edition) safety standards, it must be handled according to manufacturer guidelines to ensure reliability and patient safety across multiple uses.

  • What types of monitoring systems is this saturation module compatible with?

    The E-MASIMO Saturation Module is designed as a single-width, plug-in module and integrates specifically with GE Datex-Ohmeda S/5 modular monitoring systems as well as compatible GE CARESCAPE platforms. It is not a standalone device but requires integration into these systems for operation.

  • How does this module improve accuracy in challenging clinical scenarios?

    The module uses Masimo SET® technology, which employs infrared and red light transillumination to measure arterial oxygen saturation (SpO₂) and pulse rate. This technology is optimized to perform reliably even in difficult conditions, such as when patients are experiencing motion artifact or low perfusion, ensuring more consistent readings in critical care settings.

  • What regulatory pathways does this device follow, and what does that mean for its use?

    The E-MASIMO Saturation Module is authorized under FDA 510(k) clearance (K081870) and MDR compliance, meaning it has undergone regulatory review to demonstrate substantial equivalence to a previously cleared device. This clearance confirms its safety and performance for noninvasive monitoring of SpO₂ and pulse rate in clinical settings where continuous monitoring is required, such as intensive care or operating rooms.